Handling of Obsolete/ Rejected Raw Material and Packing Materials

 

The objective of Obsolete/ Rejected Raw Material and Packing Materials

  • To lay down a procedure for Handling Obsolete/ Rejected Raw Material and Packing Materials.

Scope Objective of Obsolete/ Rejected Raw Material and Packing Materials

  • This Standard Operating Procedure is applicable to Raw Materials and Packing Materials for the handling of Obsolete/ Rejected Raw Material and Packing Materials in the formulation plant of the Pharmaceutical company.

Responsibility Objective of Obsolete/ Rejected Raw Material and Packing Materials

  • Raw material Store and Packing material store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Raw material Store and Packing material store in-charge shall be responsible for the implementation of the procedure mentioned in this SOP.

Accountability Objective of Obsolete/ Rejected Raw Material and Packing Materials

  • Store Incharge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP: Standard Operating Procedure; a document where step-by-step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA: Quality Assurance
  • QC: Quality Control
  • Deptt. : Department

Ltd.: LimitedRejected Raw Material

Procedure 

Handling of Obsolete/ Rejected Raw Material

Rejection of Raw Materials at the time of receipt:-

  • At the time of receipt of Raw Materials, if it is damaged to the extent of contaminating the raw materials, the material shall be rejected from the gate itself at the discretion of the Factory Manager and RM Store In-charge.
  • On the receipt of the raw material, the raw material store in charge shall be intimate to the QC Deptt. For taking a sample. The QC department shall take a sample of the raw material to confirm if the material Supplied is as per the specifications.
  • If the sampled raw material complies with the specifications then the material shall be released and raw material shall be labeled with the Status label of “Released”.
  • If the supplied raw material does not comply with the specification after testing, the same shall be declared rejected material by the QC Deptt.
  • QC Deptt. shall send the test report to the raw material store for taking necessary steps for Destruction or return of the rejected material to the supplier, as the case may be.
  • The rejected raw material shall be kept in the “Rejected Materials Store” area with a label of ”REJECTED” duly filled and signed by RM Store In-charge and shall be sent back to the supplier after proper documentation.

Rejection of Raw Materials at the time of re-test:-

  • The material, if rejected at the time of re-testing, shall be kept in the “Rejected Materials Store” area for destruction with a label “REJECTED” duly filled and signed by RM Store In-charge.
  • The rejected material shall be destroyed as per the procedure laid down in SOP titled “Disposal & Destruction of materials” after getting necessary approval from the Managing/Executive Director.

Handling of Obsolete Raw Materials:-

  • The materials which are lying in-store and are expired or not in a condition to be of any further use shall be stored in the “Rejected Material Store” for destruction with a label “Obsolete” duly filled and signed by Raw material store In-charge.
  • The obsolete material shall be destroyed as per the procedure laid in the SOP titled “Disposal & Destruction of materials” after getting necessary approval from the Managing/Executive Director.

Approval for the destruction of Rejected/Obsolete Raw Material:-

  • Necessary approval for the destruction of Rejected/Obsolete raw Materials shall be obtained from the Managing/Executive Director prior to the destruction of such material on the approval letter given in Annexure-I.
  • The approval record shall be retained by RM Store In-charge.
  • Proper entries shall be made in Raw Material Stock Register and information shall be sent to the Excise department to get the entries done in their respective records to be destroyed.

Handling of Obsolete/ Rejected Packing Material

Rejection of Packing Materials at the time of receipt:-

  • At the time of receipt of Packing Material if it is found damaged to the extent of affecting the quality of the Packing materials the material shall be rejected from the gate itself on the Discretion of Packing Material Store In-charge and Factory Manager.
  • All unprinted Packing materials, if rejected after testing, shall be kept in rejected Packing Materials Storage area with a label of REJECTED duly filled and signed by Packing Material Store In-charge and shall be sent back to the supplier after proper documentation.
  • All printed Packing materials if rejected after testing, shall be kept in rejected Packing Materials Store area with a label of REJECTED duly filled and signed by Packing Material Store In-charge and shall be subsequently destroyed as per SOP titled “Disposal & Destruction of materials”.
  • On the receipt of the packing material, the packing material store in charge shall intimate to the QC Deptt. For taking sample The QC Department shall take a sample of the packing material to confirm if the material Supplied is as per the In-House specifications.
  • If the sampled packing material complies with the In-House specifications then the material shall be released for consumption in packing of finished goods and packing shall be labeled with the Status label of “Released”.
  • If the supplied packing material does not comply with the In-House specification, the same shall be declared rejected material by the QC Deptt.
  • QC Deptt. shall send the test report to the packing material store for taking necessary steps for Destruction or return of the rejected material to the supplier, as the case may be.

Rejection of Packing Materials at the time of re-testing:-

  • The material, if rejected at the time of retesting, shall be kept in rejected Packing Materials Storage area with a label REJECTED duly filled and signed by the PM Store In-charge.
  • The rejected Packing Material shall be destroyed as per SOP titled as, “Disposal & Destruction of materials” after taking necessary approval from the Managing / Executive Director.

Handling of obsolete printed Packing Materials:

  • Printed Packing Materials shall be considered obsolete when there is a change in pharmaceutical specifications or any other legal requirements or otherwise not fit for use in the packing of finished products.
  • The above Packing materials shall be kept in rejected materials area under lock and Key.
  • All materials, which are lying in-store and are not in a condition to be of any

Further use, shall be destroyed as obsolete materials as per SOP titled “Disposal & Destruction of materials” after taking the approval from the Managing / Executive Director. All the rejected packing materials shall be stored under lock and key in a separate room bearing the label of Rejected Materials.

Approval for the destruction of Rejected/obsolete printed Packing Materials

  • Necessary approval for the destruction of Rejected / obsolete printed Packing material shall be obtained from the Managing / Executive Director prior to the destruction of such material on the approval letter given in Annexure-II.
  • The approval record shall be retained by Packing Material Store In-charge.

Forms and Records (Annexures)

  • Approval for the Destruction of Rejected/Obsolete Raw Materials    –         Annexure-I
  • Approval for the Destruction of Rejected/Obsolete Packing Materials  –    Annexure-II

Distribution

  • Master copy  –     Quality Assurance
  • Controlled copies   –      Quality Assurance, Raw Material Store, Packing Material Store

History

    Date    Revision Number
                 Reason for Revision
                    New SOP

Annexure-I

Approval for the Destruction of Rejected/Obsolete Raw Materials

From:  Raw ……..Material Store

To:  Managing / Executive Director

Rejected Sir,.

The raw material(s) mentioned below has/have been declared not of standard quality / Expired / Obsolete and hence not in a condition for any further use in the manufacture of drugs. Kindly accord the necessary approval for the destruction of the same. Test Report of the QC Analyst verified by the QC Manager and QA Manager is attached herewith for your consideration, please. Details of the Raw Material(s) to be destroyed are:

S. No.Name of Raw MaterialB. No.Expiry DateMfd. BySupplied ByQuantity in StockReason for destruction

 

  In-charge R.M. Store

  Directions of Managing / Executive Director. 



       

Date __________________                                                                             Managing / Executive Director

                                                                                 

 

                                                                                     Annexure-II   

                              Approval for the Destruction of Rejected/Obsolete Raw Materials    

From:  Packing Material Store

To:  Managing / Executive Director

Rejected Sir,

The Printed Packing Material(s) mentioned below has/have been declared not of standard quality / Expired / Obsolete and hence not in a condition for any further use in the manufacture of drugs. Kindly accord the necessary approval for the destruction of the same. Test Report of the QA Inspector verified by the QA Manager is attached herewith for your consideration, please. Details of the Raw Material(s) to be destroyed are:

S.noPacking materialSupplied byQuality stockReason of destraction

In-charge PM Store

Directions of Managing / Executive Director.

 

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About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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